Effects of electroacupuncture therapy for depression: study protocol for a multi-centered, randomized controlled trial

Background As a major public health problem, depression has a negative impact on individuals and society. The aim of this well-designed trial is to evaluate the efficacy and safety of electroacupuncture (EA) treatment for depression. Methods/Design A three-arm parallel, non-blinded, randomized controlled trial was performed in four hospitals (centers). 144 participants will be divided into three groups: electroacupuncture (EA) group, hand acupuncture (HA) group and western medicine group. Participants in EA group and HA group received 12 sessions of acupuncture treatment for 4 weeks. Participants allocated to western medicine group will only take 20mg fluoxetine orally per day for 4 weeks. The primary outcome is Hamilton Depression Scale (HAMD). Secondary outcomes are Self-Rating Depression Scale (SDS), Depression Scale of traditional Chinese medicine (Depression Scale of TCM), brain fMRI and blood biomarkers including neurotransmitters 5-HT, DA, NE, inflammatory cytokines IL-1β, TNF-α, IL-6 and neurotrophin BDNF. All the outcomes will be assessed at baseline, 4 weeks after EA treatment onset and 6-month follow-up. Discussion The results of this trial will verify the efficacy and safety of EA treatment for depressive patients and provide acupuncturists and clinicians with robust clinical evidence.